FDA greenlights new COVID-19 tests, anti-coagulant drug

Jul 20, 2020 - 02:39 PM
FDA product update

The Food and Drug Administration last week reissued its emergency use authorization of Quest Diagnostics’ SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation.

The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples, which FDA said is an important public health tool because it allows for more people to be tested quickly using fewer testing resources.

FDA also authorized the emergency use of a pair of qualitative tests for detecting SARS-CoV-2 antibodies and nucleic acids. Boston Heart Diagnostics’ molecular Boston Heart COVID-19 RT-PCR Test and Luminex Corporation for its serology xMAP SARS-CoV-2 Multi-Antigen IgG Assay are approved for use for the duration of the COVID-19 public health emergency.

Finally, the agency approved an abbreviated new drug application for anti-coagulant heparin sodium. FDA says the drug, which prevents blood clotting, will help meet increased demand for such products during the COVID-19 public health emergency.

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